Implementation of HBB Training With Facilitators That Have Undergone Simulation Methodology Training (SimHBB)

A Comparison of the Implementation of HBB Training Using Facilitators With and Without Simulation Methodology Training

Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths and reduction in fresh stillbirths. HBB has successfully integrated some aspects of simulation into an educational curriculum that teach the management of neonatal emergencies in resource-constrained countries.

Simulation based training brings special advantages and may enhance HBB training. Critical elements of simulation such as enhanced realism and post-event debriefing may carry potential to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness of this combined approach is limited.

Study Overview

Detailed Description

Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths and reduction in fresh stillbirths. HBB has successfully integrated some aspects of simulation into an educational curriculum that teach the management of neonatal emergencies in resource-constrained countries.

High levels of physical, emotional and conceptual realism are important features of simulation-based learning that impact learning outcomes. Formal debriefing is characterized as the most important element of simulation based education. Structured feedback in a safe learning environment provides the opportunity for learning of clinically relevant material. Guided reflection transfers the responsibility for learning to the participants and solidifies knowledge, skills and behaviors for transfer to clinical practice.

Simulation based training brings special advantages and may enhance HBB training. Critical elements of simulation such as enhanced realism and post-event debriefing may carry potential to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness of this combined approach is limited.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bushenyi
      • Ishaka, Bushenyi, Uganda, 256
        • Recruiting
        • Kampala International University
        • Contact:
          • Cathy Kyakwera, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Only trained facilitators are eligible to participate
  • Must hold a Faculty position or are a health care provider at KIU Teaching Hospital in western Uganda
  • Are engaged in teaching health students.
  • Participating medical students are those enrolled at KIU Teaching Hospital in western Uganda

Exclusion Criteria:

  • Faculty and hospital workers who are not engaged in teaching health students.
  • Medical students not enrolled at KIU Teaching Hospital, western Uganda

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HBB plus simulation training
Participants receive training from facilitators for HBB training with simulation skills
HBB training from facilitators with simulation skills. Standard HBB facilitators do not have simulation skills
No Intervention: Control
Participants receive training from facilitators for HBB training without simulation skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge
Time Frame: Change in knowledge scores at 6 months from Baseline
The primary outcome for this analysis is level of knowledge. For each course, learners will be assessed at baseline and at course-end to determine their knowledge via multiple choice test. Scores out of 100% will be computed
Change in knowledge scores at 6 months from Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical skills
Time Frame: Change in clinical skills at 6 months from baseline
The clinical skills outcome (via short neonatal resuscitation simulation scenario - HBB OSCE B). HBB OSCE B assessment will be conducted by the facilitator.
Change in clinical skills at 6 months from baseline
Facilitator debriefing skills
Time Frame: Change in facilitator skills at 6 months from baseline
Facilitator debriefing skills will be assessed using the OSAD. OSAD assessments will be conducted by a pre-trained rater who will rate facilitator performance in real time.
Change in facilitator skills at 6 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2017

Primary Completion (Anticipated)

December 30, 2018

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 19, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MUST 21/06-16c

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data will be shared after appropriate permissions have been obtained.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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